- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07924761
A Study to Investigate the Effect of Injection Site and Ethnicity on KAI-4729 Pharmacokinetics in Non-Asian and Asian Participants Living With Obesity or Overweight
A Phase 1, Randomized, Open-Label, Single-Dose Study to Investigate the Effect of Injection Site on Relative Bioavailability of KAI-4729 Subcutaneous Injection and Pharmacokinetics of KAI-4729 in Non-Asian and Asian Participants Living With Obesity or Overweight
The main objectives of this study are to assess the relative bioavailability of KAI-4729 subcutaneous (SC) injection in the upper arm and thigh compared with the abdomen and to measure the pharmacokinetics of KAI-4729 in plasma following a single SC dose in healthy non-Asian and Asian participants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kailera Therapeutics, Inc.
- Numéro de téléphone: 1-781-317-0291
- E-mail: info-clinicalstudies@kailera.com
Lieux d'étude
-
-
California
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Anaheim, California, États-Unis, 92801
- Kailera Clinical Site
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Key Inclusion Criteria:
- Have a body mass index (BMI) ≥25 and ≤40 kilograms per square meter at screening (Days -28 to -2) and on Day -1 of the first Treatment Period
- Non-Asian Participants Only: Be of non-Asian descent and not identify as being of East Asian origin
- Asian Participants Only: Be of Asian descent, identify as being of East Asian origin, and have both parents and both sets of grandparents born in East Asia and of East Asian descent
- Medically healthy
Key Exclusion Criteria:
- Have estimated glomerular filtration rate <60 milliliters/minute/1.73 square meters at screening (Days -28 to -2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration calculation.
- Have hemoglobin A1c test result ≥6.5% or blood glucose ≥126 milligrams/deciliter (≥7 millimoles/liter) at screening (Days -28 to -2).
- Have a history of, or positive test results at screening (Days -28 to -2) for, human immunodeficiency virus (HIV), hepatitis B surface antigen, or active hepatitis C virus infection.
- Have positive drugs of abuse or alcohol test results at screening (Days -28 to -2) or on Day -1 of each Treatment Period.
- Be pregnant or planning to be pregnant and/or breastfeeding or planning to breastfeed during the study and within 5 half-lives of the study drug (25 days) following the last study treatment dose.
- Have any history of malignant disease, including in situ cervical or prostate cancer, within the 5 years prior to informed consent (excludes basal or squamous cell carcinoma that was successfully treated).
- Have history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the 3 months prior to informed consent determined by the Investigator (or delegate) to be clinically relevant.
- Have known hypersensitivity to the study drug; glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide, and/or glucagon receptor agonist therapies; or any of the study drug ingredients.
- Have any other conditions or received prior therapy that, in the opinion of the Investigator (or delegate), would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Upper Arm Injection Site
Participants will receive KAI-4729 as a single SC injection into the upper arm on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Expérimental: Abdomen Injection Site
Participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Expérimental: Thigh Injection Site
Participants will receive KAI-4729 as a single SC injection into the thigh on Day 1 of either Treatment Period 1, 2, or 3. |
SC injection |
|
Expérimental: Abdomen Injection Site (Asian Participants)
Asian participants will receive KAI-4729 as a single SC injection into the abdomen on Day 1 of Treatment Period 1. |
SC injection |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of KAI-4729 in the Upper Arm and Thigh Compared to the Abdomen
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose
|
|
Cmax of KAI-4729 in Healthy Non-Asian and Asian Participants
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-t of KAI-4729 in Healthy Non-Asian and Asian Participants
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
|
AUC0-inf of KAI-4729 in Healthy Non-Asian and Asian Participants
Délai: Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Treatment Period 1, 2 and 3: Pre-dose and up to 29 days post-dose; Treatment Period 1: Pre-dose and up to 29 days post-dose (Asian Participants)
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Délai: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Délai: Day 1 to Day 99
|
Day 1 to Day 99
|
|
Number of Participants Who Experience Antidrug Antibodies (ADAs) to KAI-4729
Délai: Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Treatment Period 1, 2 and 3: Day 1, Day 8, Day 29 post-dose
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Medical Director, Kailera Therapeutics, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- K4729-1115
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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